MAXALT MAX 10 mg ORAL LYOPHILIZED

Introduction

Package Leaflet: Information for the User

MAXALT MAX 10mg Oral Lyophilisate

rizatriptan

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What MAXALT MAX is and what it is used for
2. What you need to know before taking MAXALT MAX
3. How to take MAXALT MAX
4. Possible side effects
5. Storage of MAXALT MAX
6. Package Contents and Additional Information

1. What MAXALT MAX is and what it is used for

MAXALT MAX belongs to a group of medications called selective serotonin 5-HT1B/1D receptor agonists.

MAXALT MAX is used to treat migraine headache attacks in adults.

Treatment with MAXALT MAX:

Reduces swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine attack.

2. What you need to know before taking MAXALT MAX

Do not take MAXALT MAX:

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medication (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure.
• if you have or have ever had heart problems, including heart attack or chest pain (angina) or have experienced signs related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke (CVA) or a transient ischemic attack (TIA).
• if you have problems with obstruction in your arteries (peripheral vascular disease).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent a migraine attack.
• if you are taking another medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see also Taking MAXALT MAX with other medicationsbelow).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking MAXALT MAX.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take MAXALT MAX if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or use nicotine substitutes, your family has a history of heart disease, you are a man over 40 years old or a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with the way your heart beats (left bundle branch block).
• you have or have had any allergy.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.
• you take herbal remedies containing St. John's Wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including pain and pressure in the chest.

If you take MAXALT MAX too frequently, this may cause you to develop chronic headache. In such cases, you should contact your doctor, as you may need to stop taking MAXALT MAX.

Tell your doctor or pharmacist about all your symptoms. Your doctor will decide if you have migraine. You should only take MAXALT MAX for a migraine attack. MAXALT MAX should not be used to treat other types of headaches that may be caused by other, more serious conditions.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication. These include herbal remedies and medications you normally take for migraine. This is because MAXALT MAX may affect how some medications work. Other medications may also affect MAXALT MAX.

Taking MAXALT MAX with other medications

Do not take MAXALT MAX:

• if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.
• if you take ergotamine-type medications, such as ergotamine or dihydroergotamine to treat your migraine.
• if you take methysergide to prevent migraine attacks.

The medications mentioned above, when taken with MAXALT MAX, may increase the risk of side effects.

After taking MAXALT MAX, you should wait at least 6 hours before taking ergotamine-type medications such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, you should wait at least 24 hours before taking MAXALT MAX.

Ask your doctor for instructions on how to take MAXALT MAX and information about the risks

• if you are currently taking propranolol (see section 3 How to take MAXALT MAX).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Taking MAXALT MAX with food and drinks

MAXALT MAX may take longer to work if you take it after meals. Although it is better to take it on an empty stomach, you can still take it even if you have eaten.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not indicate an increased risk of birth defects. It is not known if MAXALT MAX is harmful to the fetus when taken by a pregnant woman after the first 3 months of pregnancy.

If you are breastfeeding, you may postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Children and Adolescents

The use of MAXALT MAX oral lyophilisate is not recommended in children under 18 years of age.

Use in Patients Over 65 Years of Age

There are no complete studies that evaluate the safety and efficacy of MAXALT MAX in patients over 65 years of age.

Driving and Using Machines

When taking MAXALT MAX, you may feel drowsy or dizzy. If this happens, do not drive or use tools or machines.

MAXALT MAX contains aspartame

This medication contains 3.75 mg of aspartame in each 10 mg oral lyophilisate, equivalent to 2.1 mg of phenylalanine.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take MAXALT MAX

MAXALT MAX is used to treat migraine attacks. Take MAXALT MAX as soon as possible after your migraine headache starts. Do not use it to prevent an attack.

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg dose of MAXALT. You should wait at least 2 hours between taking propranolol and MAXALT, up to a maximum of 2 doses in a 24-hour period.

If the migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine recurs, you can take an additional dose of MAXALT MAX. You should always wait at least 2 hours between doses.

If after 2 hours you still have a migraine

If you do not respond to the first dose of MAXALT MAX during an attack, you should not take a second dose of MAXALT MAX to treat the same attack. However, you may still respond to MAXALT MAX during the next attack.

Do not take more than 2 doses of MAXALT MAX in a 24-hour period (for example, do not take more than two 10 mg tablets or oral lyophilisates in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer MAXALT MAX oral lyophilisate

• MAXALT MAX (rizatriptan benzoate) is available as a 10 mg oral lyophilisate that dissolves in the mouth.
• Open the blister pack of the MAXALT MAX oral lyophilisate with dry hands.
• Place the oral lyophilisate on your tongue, where it will dissolve so that it can be swallowed with your saliva.
• The oral lyophilisate can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

MAXALT is also available in tablets to be taken with liquids.

If you take more MAXALT MAX than you should

If you take more MAXALT MAX than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

Signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The following side effects may occur with this medication.

In adult studies, the most frequently reported side effects were dizziness, drowsiness, and fatigue.

Frequent (affect 1 to 10 in every 100 patients)

• tingling sensation (paresthesia), headache, decreased sensitivity in the skin (hypoesthesia), decreased mental sharpness, insomnia.
• rapid or irregular heartbeat (palpitations).
• flushing (redness of the face that lasts a short time).
• throat discomfort.
• nausea, dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

Infrequent (affect 1 to 10 in every 1,000 patients)

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremors, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flashes, sweating.
• skin rash, itching, and rash with hives (urticaria); swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• feeling of stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or frequency (arrhythmia); alterations in the electrocardiogram (a test that records the electrical activity of your heart), very rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affect 1 to 10 in every 10,000 patients)

• breathing sounds.
• allergic reaction (hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).
• slow heart rate (bradycardia).

Frequency not known (frequency cannot be estimated from available data)

• heart attack, spasms of the heart's blood vessels (these usually occur in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).
• a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations.
• severe skin peeling with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/fits).
• contraction of blood vessels in the limbs, including cooling and numbness of hands and feet.
• contraction of blood vessels in the colon (large intestine), which can cause abdominal pain.

Tell your doctor immediately if you have symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

Also, tell your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking MAXALT MAX.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MAXALT MAX

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton/outer packaging/ pouch/blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not remove the blister pack of the oral lyophilisate from the outer aluminum pouch until you are about to take the medication it contains. Do not use the medication if the aluminum pouch is damaged.

Always keep the aluminum pouches inside the carton.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of MAXALT MAX

• The active ingredient is rizatriptan. One oral lyophilisate contains 10 mg of rizatriptan equivalent to 14.53 mg of rizatriptan benzoate.
• The other components are gelatin, mannitol (E-421), glycine, aspartame (E-951), and peppermint flavor (composed of peppermint essence, maltodextrin, and dextrin).

Appearance of the Product and Container Content

The MAXALT MAX oral lyophilisates are white or off-white, round, with a modified square on one face, with a peppermint flavor.

Container sizes: containers with 2, 3, 6, 12, or 18 oral lyophilisates.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany MAXALT lingua 10 mg Schmelztabletten

Austria, Finland, Sweden MAXALT RAPITAB

Belgium, Luxembourg MAXALT LYO 10 mg

Denmark MAXALT Smelt, smeltetabletter

Spain MAXALT MAX 10 mg

France MAXALT LYO

Greece MAXALT Rapid Sol. Tab.

Italy MAXALT RPD 10 mg oral lyophilisate

Iceland MAXALT SMELT 10 mg frostþurrkaðar töflur

Ireland Rizatriptan MSD 10 mg oral lyophilisates

Lithuania MAXALT 10 mg geriamieji liofilizatai

Norway Maxalt Rapitab

Netherlands MAXALT SMELT

United Kingdom MAXALT MELT

Romania Maxalt 10 mg liofilizat oral

Date of the Last Revision of this Leaflet:07/2024.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)